Guest Post: Does the FDA Think You’re Stupid?

Does the FDA think you're too stupid to have access to your own genetic information?

It sure seems so.

The Food and Drug Administration, which bills itself as "the oldest comprehensive consumer protection agency in the US federal government," probably stirs up more emotion among citizens than any other federal agency (save perhaps for the IRS). For good reason. The range of activities into which the FDA is "mandated" to poke its supervisory fingers is vast and includes most prominently the regulation of most types of foods, dietary supplements, medical devices, human and veterinary drugs, vaccines and other biological products, and cosmetics.

And this time it's really gone too far.

On November 22, 2013, the FDA sent a warning letter to the well-known consumer genomics company 23andMe, ordering it to "immediately discontinue marketing" its only product.

For those of you who are not familiar with 23andMe, the company provides a "DNA Spit Kit" and "Personal Genome Service" (PGS) that supposedly reports on 240+ health conditions and traits and helps clients track their ancestral lineage. Basically, you send a saliva sample in via the "Spit Kit," and the company analyzes the sample using a DNA sequencing machine.

It doesn't give you a full readout of your genome, but tests for a custom panel of what are called single nucleotide polymorphisms in order to determine, for instance, if you're a carrier for certain disease-linked mutations like cystic fibrosis or sickle cell anemia. The panel also tests for the three most common BRCA1 and 2 mutations that are associated with breast cancer, among many other mutations associated with other diseases.

So what we're talking about here with 23andMe is information, not a medical device. It's your personal genetic information. And the FDA wants to put the kibosh on one of the only companies providing this service inexpensively—you get your Spit Kit and readout for just $99—to consumers.

This is really a first amendment issue, and the FDA should not be in the business of regulating freedom of speech and information. But considering what the FDA thinks of your intelligence, I'm not surprised they're trying to reach this far.

Consider some of the language from the FDA's warning letter to 23andMe.

"For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist."

Really? You think that if a woman receives news from a $99 test that she may be at a higher risk for breast cancer due to a genetic mutation that she's going to run out and somehow acquire chemo drugs and start dosing herself, or that she's going to go to some back-alley clinic to have her breasts lopped off? Not to be crude or make light of a very serious situation and condition, but the FDA's implication is insulting, to say the least.

What would actually happen in the real world is that she'd go to a doctor to get herself checked out, perhaps sooner rather than later, which isn't a bad thing even if the 23andMe test showed a false positive. Now, if the test showed a positive for the mutation and she is in fact positive—which would have to be confirmed by a separate test from a doctor anyway before a mastectomy—it is her right to undergo such surgery whether or not it is determined to be "medically necessary." This is precisely what Angelina Jolie recently did.

The false negative argument is maybe a little more plausible, but despite what the FDA might believe, people who are proactive enough about their genetic makeup to seek out a service like the PGS from 23andMe are smart. They know that no test is foolproof or 100% accurate. People receive false negative tests from federally regulated labs and physicians all the time. It's unfortunate, but that's the way these things work. You don't see anybody making a stink that these tests shouldn't be run just because there's a small chance of delivering a patient a false negative result.

In response to the FDA's warning letter, 23andMe has stopped all TV, radio, and online advertising for its PGS, although the service is still being sold on the website. The situation is still unfolding, so whether or not the FDA decides that the company is now in compliance because it's no longer "marketing" the PGS remains to be seen. It could determine that just having the website active is a form of "marketing," which could be the nail in the coffin for the company. We'll have to see. According to the FDA, 23andMe had 15 working days (starting November 22) to notify it of the specific actions the company has taken to address all of the issues raised in the letter.

As expected, an additional consequence of the FDA's warning letter is a class action lawsuit that was filed just five days after the letter was sent. The lawsuit alleges that the test results are "meaningless," and that 23andMe uses false and misleading advertising to promote its services to US consumers. The lawsuit seeks at least $5 million under various California state laws and estimates "tens or hundreds of thousands" of US customers are entitled to damages from the company.

Look, I get that many of you probably think the FDA had every right to do what it did. And I'll admit that its actions probably were legally justified, since 23andMe's advertising campaign did seem to market the PGS "for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease," which falls under the FDA's purview.

I also understand why detractors of consumer genomics companies think the FDA should shut down 23andMe and all its peers/competitors—because people engaging the services of these companies don't get the full picture, and what's going on is much more complex. Only part of a person's DNA is tested, and how to properly interpret the results is still uncertain, since many factors other than a mutation in isolation contribute to disease.

But when do we ever get the full picture? Even a readout of our entire genome is only a small part of the story. A key takeaway from what's known as the ENCODE Project is that much of what was previously thought of as "junk DNA" actually performs regulatory functions—which can be thought of as regions that act like switches attached to a particular gene that determine whether or not they'll be expressed. There are millions of such regions throughout the genome, and they're linked to each other (and to the protein-coding genes) in an extremely complicated hierarchical network.

What's more, the linear ordering of the genome provides a further source of confusion: the three-dimensional folding of the chromosomes inside the nucleus allows promoter regions to maintain a close connection to genes that apparently lie far away on the linear sequence. This explains why so much biochemical activity can be found even deep in the deserts of the alleged "junk DNA."

Many of these promoter regions manifest themselves in the cell as "functional RNA" molecules—types of RNA that are an end product in themselves, rather than merely an intermediate step on the way to becoming a protein, and that play a key role in switching genes on and off.

In truth, we never get the full story, no matter whom we turn to, and there's nothing wrong with bits and pieces of information to help us make decisions along the way (or just to satisfy our curious nature).

And that's really the whole point here. I don't really care if what the FDA did was technically legal or that some people think it makes sense in order to keep others from harming themselves in some way. What matters is that this ultimately boils down to information—personal genetic information. And whether 23andMe does a good job of providing that or not, it's our right to seek out such a service and use it if we so desire.

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I can no longer sit back and allow Communist infiltration, Communist indoctrination, Communist subversion, and the international Communist conspiracy to sap and impurify all of our precious bodily fluids.

To our overlords, we are all just tax donkeys to be ridden until we drop; farm animals to be variously milked, sheared, and slaughtered; criminals to be jailed for attempting to see to our own needs; and traitors to be executed for seeking knowledge, to say nothing of enlightenment, outside the razor-thin corridors of Establishment Indoctrination.

If you choose among them at the ballot box, you are merely perpetuating the horrors they daily visit upon us.

People should not be getting their genetic profiles through this company with the fancy medical analyzing equipment, they should be going to their friendly neighborhood fortune teller with the crystal ball.

I've had my DNA done by 23andMe and nothing they have told me could be construed as medical advice. I find it suspicious that a couple of months after the CEO, Anne Wojcicki, separated from her husband Sergey Brin, co-founder of the NSA department currently known as 'Google', the FDA decides it needs to roil the waters with such a farcical claim. So if I find out I'm 10% more likely to come down with some form of cancer I'm going to try have elective surgery to preventive it and somehow the surgeons will go along with it? It seems to me like another .GOV selective enforcement of the law, almost like we were living in Chicago or something.

Were you ever tested for the good luck gene? I mean you never know WTF can happen from now till you max out your life expectancy. One of my grandmas was 89 and got hit by a car walking to the pharmacy. Not kidding.

Like hit by a car, dead? One of my grandmas drove her car off into the deep woods because she was bringing her (older) sister a pie. She was technically deaf and ravaged by rheumatoid arthritis. So, she noticed that the pie was sliding off the passenger seat. While trying to reach the pie she inadvertently went full throttle and starboard.

The property owner found her, trapped in her car which was wedged between a couple trees.

The reason 23&Me got into trouble is that they basically are offering the test for "entertainment purposes only" but the website makes it sound like they are making health claims. The FDA warned them about making unfounded health claims to which 23&Me ignored. The testing protocol used by 23&Me, at least in terms of testing for BRACA1 and BRACA2 for instance, is also next to useless unless you are an Azkenazi Jew (the specific mutation tested for is mainly found in that population). In other words, the information could be completely misleading (ie 23&me says no mutation, yet you have a different mutation not tested for). Speaking of which, they do not published error rates, either for false positives or negatives. There's a whole slew of problems with their test. If you want to get useful genetic health information, you are better off elsewhere.

Then there's the whole issue that Google keeps all of your genetic info with reservations to do whatever they want with it.

yeah, too bad everything the movie said as satire pretty much turned out to be true. would you like some aspertame with that fluoride to wash down those GMO cornchips? funny that the biggest danger isn't the chemicals in the water, it's the textbooks in the classrooms.

I guess I'm odd man out on this one. I figured the gubbermint was behind these spit test sites on the internet.They have been uber interested to set up a DNA database of Amerikans for a very long time. Most folks I know won't send in a saliva sample cause word is they are looking for donor matches for organs and other nasty deeds. Insurance agents were pushed into getting saliva samples from new applicants starting about 15 years ago but many refused to oblige. There have been programs to get dna from mouth swabs of children also. If you are a match for some rich asshat looking for a liver you may find yourself disappeared.

Oh yeah I forgot to include in the above post that recently during routine police roadblocks, the vehicle occupants were required to give the police a dna mouth swab sample. Now why would they need that? No it wasn't for alcohol detection.

Good news is caffeine is have powerful preservative characteristic. Just before die, have drink of 1000 ml Big Gulp™ and you are save family for embalming cost... or drink Smirnoff and save on incineration cost with flammable accelerant.

Huxley's 'soma' is borrowed from Vedic traditions where soma was once a concoction of one or more elixirs that got you a little high. These majestic poets would travel across the lands, load up on soma (Sanskrit-derived languages have Monday as the day of soma...), and sing tales of their gods and journeys.

Soma did not destroy the original Aryans - in fact they were never 'destroyed' in the way most other cultures perished.

However Huxley's 'soma' is indeed where we are at today, and its primary incarnation is bigPharma and bigAgra. They've only touched the tip of killing you softly.

I must admit I was shocked to have been prescribed Soma when I had to go to urgent care for terrible back pain. Was this a joke to name a med as such? I will admit it helped the pain but at a cost of making me a drooling mind numbed idiot for a day. I guess it was aptly named. I can't imagine why people get hooked on that stuff. Scotch is far more pleasurable IMHO.

One of my good friends ODd on pills twice, the second time nearly fatal. They have a grip on your life like none other - it's an "I don't think I can exist without this stuff" feeling, I was told. I don't know what that's like, but it's really fucked up shit.

He did agree with me about the general fallacy of quitting stuff, that you gotta go out with a bang and just quit. Just like how those 15 extra pounds didn't show up overnight, and won't go away overnight, neither does a lifestyle incorporation. The great thing about human body resilience + sapience is that with a lot of discipline and a little bit of determination, anyone can change their bodily habits from one lifestyle to another over the course of six months, step by step.

Smoke two packs a day? How about one cigarette less for a week, and one less the week after... surely the day will come when even the one cigarette a day seems nasty to you. Concentrating on the end goal only leaves no room for a journey.

p.s. modern medicine is a disgrace - they named it 'soma' out of mockery.

Yes, this can work. I have done it myself to overcome some personal addictions. First of all I made a decision I wanted to quit. I engage help from a cognitive psycologist who showed me a few techniques to help. I had always gone cold turkey with a eventual hard core binge. She showed me how to slowly reduce my addiction always without personal judgement. If I failed and binged it was ok, just a bump in the road and moved on.

I also explored some skeletons in my personal closet that needed to be buried. That was a painful exercise but it relieved me of inappropriate guilt and lessened the need for binges. She also stressed I needed to ramp up the natural joy in my life as I was eliminating the temporary artificial highs. It worked for me. I'm no prude or try to force myself in abstention. I just enjoy life and all of its pleasures in moderation.

I truly feel sorry for those who are in the clutches of horrible addictions. When you are there, it's as if you are in a deep dark pit with no means to escape. I was fortunate to have found my way out.

This has more to do with the pay to play monopoly game created by govt corruption than health concerns. Today only one company can run the BRAC testing by edict of the FDA. Myriad Genetics has paid to play and now charges $1800 Dollars for the testing by having the monopoly.

'EPA now allowing 27,000 times the previous limit of iodine-131 in drinking water'

"After years of internal deliberation and controversy, the Obama administration has issued a document suggesting that when dealing with the aftermath of an accident or attack involving radioactive materials, public health guidelines can be made thousands of times less stringent than what the U.S. Environmental Protection Agency would normally allow."